FDA.reportPublic FDA data

AERO DV®

Primary DI
00884450690857
Brand
AERO DV®
Company
Merit Medical Systems, Inc.
Model
00884450690857
Catalog number
90129-315/D
Published
2024-01-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
JCTProsthesis, tracheal, expandable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JCTProsthesis, Tracheal, ExpandableGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884450690857PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884450690857008844506908578844506908570884450690857

GMDN Terms#

Term, Definition table
TermDefinition
Polymeric tracheal/bronchial stent, non-bioabsorbableA non-bioabsorbable tubular device intended to be implanted into the trachea and/or a bronchus/bronchiole to maintain luminal patency, typically used in cases of obstructions/stenoses, fistulae, tumours, scarring, surgical resection and anastomosis, or pulmonary transplantation. It is made entirely of a synthetic polymer(s) [e.g., silicone] and may have various designs (e.g., semi-soft continuous tube, covered or non-covered mesh structure, straight or branched configuration) intended to conform to the endotracheal/endobronchial surface. It may be expandable in situ (e.g., self-expands) and disposable devices intended to assist implantation may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
184763290
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884450163344Merit Medical®Initial ReleaseK09-11661B2026-07-18
00884450486627Merit Medical®Initial ReleaseK12T-09218A2026-07-18
00884450486641Merit Medical®Initial ReleaseK12T-127262026-07-17
00884450486849Merit Medical®Initial ReleaseK12T-127272026-07-17
10884450708955Prelude®FPSI-8F-11-035-18G2026-07-18
00884450014523ReSolve®, StayFIX®,ARLCMB-NV-10-SFX2026-07-16
00884450161777Merit Medical®Initial ReleaseK09-10897B2026-07-16
00884450432075Merit Medical®Initial ReleaseK11-01125B2026-07-16
00884450434482Merit Medical®Initial ReleaseK10-05031A2026-07-14
00884450493182Merit Medical®Initial ReleaseK09-09809C2026-07-14
00884450493199Merit Medical®Initial ReleaseK11-014882026-07-14
00884450108765Merit Medical®Initial ReleaseK09-10721A2026-07-10
00884450450949Merit Medical®Initial ReleaseK09-143532026-07-11
00884450487334Merit Medical®Initial ReleaseK11-014852026-07-10
00884450487341Merit Medical®Initial ReleaseK12-127232026-07-10
00884450492956Merit Medical®Initial ReleaseK10T-061782026-07-11
00884450486436Merit Medical®Initial ReleaseK09-144172026-07-09
00884450488812Merit Medical®Initial ReleaseK17-00021A2026-07-09
00884450437698Merit Medical®Initial ReleaseK09-09854C2026-07-08
00884450468913DuraMax®CH7871030280252026-07-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450690765AERO DV®Merit Medical Systems, Inc.JCT2025-06-10
00884450690833AERO DV®Merit Medical Systems, Inc.JCT2024-05-22
00884450690758AERO DV®Merit Medical Systems, Inc.JCT2024-03-30
00884450703991AERO®Merit Medical Systems, Inc.JCT2024-03-27
00884450703960AERO®Merit Medical Systems, Inc.JCT2024-03-26
00884450690796AERO DV®Merit Medical Systems, Inc.JCT2024-03-22
00884450703984AERO®Merit Medical Systems, Inc.JCT2024-03-21
00884450704004AERO®Merit Medical Systems, Inc.JCT2024-03-19
00884450703939AERO®Merit Medical Systems, Inc.JCT2024-03-16
00884450704011AERO®Merit Medical Systems, Inc.JCT2024-03-16
00884450703922AERO®Merit Medical Systems, Inc.JCT2024-03-09
00884450703946AERO®Merit Medical Systems, Inc.JCT2024-03-08
00884450703977AERO®Merit Medical Systems, Inc.JCT2024-03-06
00884450690734AERO DV®Merit Medical Systems, Inc.JCT2023-12-16
00884450690864AERO DV®Merit Medical Systems, Inc.JCT2023-12-13
00884450691403AERO DV®Merit Medical Systems, Inc.JCT2023-11-15
00884450690789AERO DV®Merit Medical Systems, Inc.JCT2023-11-10
00884450690840AERO DV®Merit Medical Systems, Inc.JCT2023-10-27
00884450691113AERO®Merit Medical Systems, Inc.JCT2023-10-13
00884450688823AEROmini®Merit Medical Systems, Inc.JCT2023-10-05
00884450690741AERO DV®Merit Medical Systems, Inc.JCT2023-10-05
00884450690819AERO DV®Merit Medical Systems, Inc.JCT2023-10-05
00884450625309AERO®Merit Medical Systems, Inc.JCT2023-09-28
00884450691069AERO®Merit Medical Systems, Inc.JCT2023-09-28
00884450691007AERO®Merit Medical Systems, Inc.JCT2023-09-26
00884450710302AEROmini®Merit Medical Systems, Inc.JCT2023-09-20
00884450624944AERO®Merit Medical Systems, Inc.JCT2023-09-16
00884450688809AEROmini®Merit Medical Systems, Inc.JCT2023-09-16
00884450688885AEROmini®Merit Medical Systems, Inc.JCT2023-09-16
00884450688892AEROmini®Merit Medical Systems, Inc.JCT2023-09-16